Key information relevant to the recruitment process for the
overall study, such as dates of the recruitment period and locations

Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Phase 3 Trial with Dapagliflozin added to Saxagliptin in Combination with Metformin compared to placebo added to Saxagliptin in combination with Metformin in Subjects with Type 2 Diabetes who have Inadequate Glycemic Control on Metformin and Saxagliptin

Pre-Assignment Details

Significant events and approaches for the overall study
following participant enrollment, but prior to group assignment

Arm1: Dapagliflozin (10 mg) + Saxagliptin + Metformin IR

Arm 2: Placebo + Saxagliptin + Metformin IR

Reporting Groups

Description

Dapa+Saxa+Met

Participants received dapagliflozin, 10 mg, and open-label saxagliptin 5 mg and metformin ≥1500 mg per day for up to 52 weeks

Pla+Saxa+Met

Participants received dapagliflozin matching placebo and open-label saxagliptin 5 mg and metformin ≥1500 mg per day for up to 52 weeks

Explanation of how the number of participants for analysis was determined.
Includes whether analysis was per protocol, intention to treat, or another method.
Also provides relevant details such as imputation technique, as appropriate.

All randomized subjects who received at least one dose of study medication

Reporting Groups

Description

Dapa+Saxa+Met

Participants received dapagliflozin, 10 mg, and open-label saxagliptin 5 mg and metformin ≥1500 mg per day for up to 52 weeks

Pla+Saxa+Met

Participants received dapagliflozin matching placebo and open-label saxagliptin 5 mg and metformin ≥1500 mg per day for up to 52 weeks